← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K160946

# 4.0 and 6.5 Cancellous Bone Screw and Washer (K160946)

_Smv Scientific · HWC · Dec 5, 2016 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K160946

## Device Facts

- **Applicant:** Smv Scientific
- **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md)
- **Decision Date:** Dec 5, 2016
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

## Device Story

Metallic bone fixation fasteners; used for fracture fixation, osteotomies, and arthrodesis. Device consists of cancellous screws and washers in various diameters and lengths. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of bone fragments to facilitate healing. Implants are non-sterile; require sterilization by user. Output is physical fixation of bone segments.

## Clinical Evidence

Bench testing only. Performance evaluated via static torsion, static axial pullout, and static removal torque per ASTM F543 standards. Results confirm mechanical strength is sufficient for intended use and equivalent to predicate devices.

## Technological Characteristics

Medical grade stainless steel; screw and washer form factor; mechanical fixation principle. Testing performed per ASTM F543 (static torsion, axial pullout, removal torque). Non-sterile; requires user sterilization.

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- 4.0 Cannulated Screws ([K111994](/device/K111994.md))
- 4.0mm and 5.0mm Locking Screws ([K000089](/device/K000089.md))
- 3.5mm and 4.0mm Cannulated Screws ([K963192](/device/K963192.md))
- 6.5mm Cancellous Screw ([K061621](/device/K061621.md))
- Spherical Washers ([K052483](/device/K052483.md))

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles, suggesting themes of health, well-being, and human connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 5, 2016

SMV Scientific % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918

Re: K160946

Trade/Device Name: 4.0 and 6.5 Cancellous Bone Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: October 21, 2016 Received: October 24, 2016

Dear Kenneth Maxwell II:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known)

K160946

Device Name

4.0 and 6.5 Cancellous Bone Screw and Washer

Indications for Use (Describe)

The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

| Type of Use (Select one or both, as applicable)                              |  |  |  |  |
|------------------------------------------------------------------------------|--|--|--|--|
| > Prescription Use (Part 21 CFR 801 Subpart D)                               |  |  |  |  |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. |  |  |  |  |
| FOR FDA USE ONLY                                                             |  |  |  |  |
|                                                                              |  |  |  |  |

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(K) SUMMARY

| Submitter's Name:                    | SMV Scientific                                                   |
|--------------------------------------|------------------------------------------------------------------|
| Submitter's Address:                 | 111 Sandra Muraida Way<br>Unit 18A<br>Austin, TX 78703           |
| Submitter Contact Person:            | Nephi Zufelt<br>Chief Technology Officer<br>512-750-8622         |
| Empirical Consulting Contact Person: | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874 |
| Submitter's Name:                    | SMV Scientific                                                   |
| Date Summary was Prepared:           | 30 November 2016                                                 |
| Trade or Proprietary Name:           | 4.0 and 6.5 Cancellous Bone Screw and Washer                     |
| Common or Usual Name:                | Smooth or threaded metallic bone fixation fastener               |
| Classification:                      | Class II per 21 CFR §888.3040                                    |
| Product Code:                        | HWC, HTN                                                         |
| Classification Panel:                | Division of Orthopedic Devices                                   |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are manufactured from medical grade stainless steel. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are offered in various diameters and lengths. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are intended to provide fracture fixation. Implants are provided nonsterile with instructions for sterilization.

## INDICATIONS FOR USE

The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g.: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies – tarsometatarsal and metatarsophalangeal arthrodeses – ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

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The indications for use for the Cancellous Screw and Washer is similar to that of the predicate devices listed in Table 5-1.

| 510k Number | Trade or Proprietary or Model Name | Manufacturer   | Type       |
|-------------|------------------------------------|----------------|------------|
| K111994     | 4.0 Cannulated Screws              | Smith & Nephew | Primary    |
| K000089     | 4.0mm and 5.0mm Locking Screws     | Synthes        | Additional |
| K963192     | 3.5mm and 4.0mm Cannulated  Screws | Synthes        | Additional |
| K061621     | 6.5mm Cancellous Screw             | Synthes        | Additional |
| K052483     | Spherical Washers                  | Synthes        | Additional |

# PERFORMANCE DATA

The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer has been tested in the following test modes:

- Static Torsion per ASTM F543 ●
- Static Axial Pullout per ASTM F543 ●
- Static Removal Torque per ASTM F543 ●

The results of this non-clinical testing show that the strength of the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is substantially equivalent to the predicate device.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K160946](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K160946)

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